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Lerado Power Wheelchair PB

by Lerado China Limited 510(k)

Active United States

510(k) K070433

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK070433 Date16 Mar 2007ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
ITI
Device Class
Class II
Regulation
21 CFR Part 890.3860
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Lerado Power Wheelchair PB is a powered wheelchair designed to provide mobility assistance. It is classified as a powered wheelchair under regulation number 890.3860.

This device is authorized under FDA 510(k) number K070433. It is manufactured by Lerado China Limited and falls under the physical medicine medical specialty.

Other devices from Lerado China Limited

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Lerado Power Wheelchair PB?

    The Lerado Power Wheelchair PB is designed to provide mobility assistance to individuals who require a powered device for movement.

  • Under which regulatory classification does this wheelchair fall?

    This device is classified as a powered wheelchair under regulation number 890.3860, which falls within the physical medicine medical specialty.

  • Is the Lerado Power Wheelchair PB authorized for use?

    Yes, this device is authorized under FDA 510(k) number K070433, which indicates it has been cleared for market distribution.